Anterior Thoracic Perforating Artery (PATA); Systematization and Applications in Reconstructive Surgery of the Head and Neck

NCT06140160 | Unknown

• 1 other identifier: 2023-A00784-41
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The use of cutaneous or fasciocutaneous flaps is daily in reconstructive surgery ENT in patients with cancers of the upper aero-digestive tract (AVDS). Cancers of the oral cavity require reconstructions with thin flaps in order to best preserve the functions of swallowing and phonation via patients' joints. Indeed, the flaps are inert tissues, which can only be mobilized by the residual muscles of the patients' tongue: their lightness and finesse facilitates this mobilization. The use of free flaps is regular but requires micro-surgical skill of the operator as well as a preserved general condition of the patients and appropriate post-operative care. Alternatively, there are some pedicled flaps with the appropriate thickness to reconstruct extensive loss of substances from the oral cavity in a suitable manner: the supraclavicular flap, the suprahyoid flap, the submental flap and the myo-mucosal flap pedicled on the facial artery being more limited in size. The creation of an anterior thoracic fasciocutaneous flap, pedicled on the anterior thoracic perforating artery (PATA) seems to be another suitable therapeutic option. Only one preliminary Chinese study describes it, on only eleven patients. According to the authors, it would offer a wide skin palette (up to 15x10cm). Its long pedicle (on average 9.2cm) would allow a significant axis of rotation so that the flap easily reaches the oral cavity. The authors underline the variability of the origin of this perforator, arising depending on the case from the transverse cervical trunk (9 cases) or from the supraclavicular artery (2 cases), branches of division of the thyro-cervical trunk. However, when the PATA arises from the supraclavicular artery, its interest could be limited because the creation of a PATA perforator flap could compromise the creation of a secondary supraclavicular flap. Thus, this study aims to clarify the feasibility of harvesting the PATA flap in the greatest number of patients. The objective is to study the variations of the anterior thoracic perforating artery necessary for the creation of this flap, by specifying its vascularization territory and its characteristics.

Conditions

Upper Aero-intestinal Tract Cancer; Supraclavicular Flap; Anterior Thoracic Perforator Artery

Outcome Measures

Primary Outcomes (3)

• Existence of the anterior thoracic perforating artery

  existence of the anterior thoracic perforating artery (PATA) : yes/no

  1 hour

• Presence of the anterior thoracic perforating artery

  the presence of the anterior thoracic perforating artery on the left and right,

  1 hour

• Origin of anterior thoracic perforating artery

  Origin of anterior thoracic perforating artery : transverse cervical trunk/ supraclavicular artery

  1 hour

Study Arms (1)

Patient with an indication for Doppler ultrasound of the supra-aortic trunks

EXPERIMENTAL

Procedure: Doppler ultrasound

Interventions

Doppler ultrasound PROCEDURE

To carry out an additional measurement using Doppler ultrasound (non-invasive examination). Doppler ultrasound measurements of the diameter and length of the perforating artery using a high-frequency Doppler ultrasound probe following a Doppler ultrasound of the supra-aortic trunks.

Patient with an indication for Doppler ultrasound of the supra-aortic trunks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient, man or woman over 18 years old,
• Patient admitted for an indication for Doppler ultrasound of the supra-aortic trunks (previously prescribed for any medical reason),
• Patient having received written information and collection of the non-opposition of the patient to participate in the study,
• Patient affiliated or beneficiary of a security regime social.

You may not qualify if:

• Minor patient,
• History of cervical surgery,
• Patients who have an inaccessible morphology to an exploration of the lower lateral cervical region, high, below and above the right and left clavicle such as the small necks, and/or with dermato-sclerosis,
• Patients who do not have the intellectual or physical allowing them to give their consent,
• Refusal to participate in the patient's study,
• Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial decision or administrative,
• Pregnant, breastfeeding or parturient woman,
• Patient hospitalized without consent.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• mermoz hospital: collaborator

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

RECRUITING

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: September 19, 2023
• Primary Completion: March 19, 2024
• Study Completion: September 19, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Locations

FR (1)